Table 2 Statistical analysis of pre-specified PRO in the SAP concepts, domain, and single items of the 17 trials reviewed.
|  | Studies with pre-specified PRO concepts (N = 17) | Instrument with domain-level analyses (N = 40) | Instrument with item-level analyses (N = 40) |
|---|---|---|---|
Longitudinal mixed model analysis | 10 (59%) | 25 (63%) | 8 (20%) |
Basic inferential test or general linear model | 2 (12%) | 6 (35%) | 0 |
 By time point | 2 (12%) | 6 (35%) | 0 |
 1-sample and 2-sample t test | 2 (12%) | 6 (35%) | 0 |
Descriptive summaries | 15 (88%) | 37 (93%) | 37 (93%) |
 Summary statistics | 15 (88%) | 37 (93%) | 37 (93%) |
 Change from baseline | 15 (88%) | 37 (93%) | 37 (93%) |
 Paired/un-paired t test | 1 (6%) | 3 (8%) | 0 |
 Cumulative distribution function figures | 1 (6%) | 2 (5%) | 0 |
Responder analysis | 9 (53%) | 21 (53%) | 7 (18%) |
 Cumulative distribution function figures | 3 (18 %) | 7 (18%) | 7 (18%) |
 Stratified CMH test | 2 (12%) | 2 (5%) | 0 |
 Stratified Cox regression | 5 (29%) | 9 (23%) | 0 |
 Unstratified log-rank test | 2 (12%) | 4 (10%) | 0 |
 Kaplan–Meier estimate | 4 (24%) | 8 (20%) | 0 |
